Source: Ministry of Health, Labour and Welfare (MHLW), Japan
“Guideline on the Microbiological Safety of Specified Cell-Processed Products” (Issued October 6, 2025)
(Official PDF, Japanese)
MHLW Regenerative Medicine Information Portal
🩺 Overview
On October 6, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) released a new national guideline titled
“Guideline on the Microbiological Safety of Specified Cell-Processed Products.”
This notice — issued by the MHLW’s Research and Development Division, Health Policy Bureau — provides detailed procedures to ensure that cell-processed products used in regenerative medicine remain free from microbial contamination throughout their production process.
The directive accompanies Japan’s amended Act on Ensuring the Safety of Regenerative Medicine and Clinical Research Law, which came into effect on May 31, 2025, following its enactment in 2024.
🔬 Key Points of the Guideline
The new guideline outlines strict responsibilities for manufacturing facilities handling cell-processed materials.
It emphasizes three major safety principles:
- Prevention of Microbial Contamination:
Producers must take all necessary measures to prevent contamination of both the processed cells and any associated materials by microorganisms or foreign agents during the entire manufacturing process. - Avoidance of Cross-Contamination:
When handling cells derived from different donors, manufacturers must ensure clear separation and traceability to prevent mixing or cross-contamination. - Personnel Hygiene and Process Control:
Detailed and rigorous operational procedures must be established to prevent contamination from staff members engaged in cell culture or processing work.
The document serves as an implementation supplement (“separate notification”) to Article 101 of the Enforcement Regulations under the Act.
It emphasizes three major safety principles:
- Prevention of Microbial Contamination:
Producers must take all necessary measures to prevent contamination of both the processed cells and any associated materials by microorganisms or foreign agents during the entire manufacturing process. - Avoidance of Cross-Contamination:
When handling cells derived from different donors, manufacturers must ensure clear separation and traceability to prevent mixing or cross-contamination. - Personnel Hygiene and Process Control:
Detailed and rigorous operational procedures must be established to prevent contamination from staff members engaged in cell culture or processing work.
The document serves as an implementation supplement (“separate notification”) to Article 101 of the Enforcement Regulations under the Act.
🧬 Background and Legal Context
Japan’s regenerative medicine sector operates under a unique three-tier legal framework:
- The Act on Ensuring the Safety of Regenerative Medicine (Law No. 85 of 2013)
- The Enforcement Order and Enforcement Regulations
- This newly issued microbiological safety guideline, referenced in the May 15, 2025 ministerial circular (Notification 0515-18)
The MHLW notes that these measures are vital to maintain the credibility and international competitiveness of Japan’s cell therapy and tissue-engineering industries.
It also clarifies that the notification has been circulated to:
- The Japan Medical Association
- The Japan Dental Association
- Accredited Regenerative Medicine Committees
- Licensed cell-processing business operators
- Other related professional organizations
🌏 Global Perspective
While the language of the document is technical and administrative, its impact is broad:
It represents Japan’s ongoing effort to tighten biosafety standards in regenerative medicine — a field rapidly expanding worldwide.
For international researchers and biotech firms collaborating with Japan, this guideline offers a clearer framework for GMP-level (Good Manufacturing Practice) compliance in cell therapy manufacturing.
In short, Japan isn’t just pushing the boundaries of regenerative medicine — it’s also fortifying the rules to make sure science remains both innovative and safe.
📎 References
- Ministry of Health, Labour and Welfare (Japan)
“Guideline on the Microbiological Safety of Specified Cell-Processed Products”
(Issued October 6, 2025 — Notification No. 1006 – 1, Research and Development Division, Health Policy Bureau)
Official PDF, Japanese (mhlw.go.jp)
- Regenerative Medicine Information Portal (MHLW)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/saisei_iryou/index.html
Short quotations from the MHLW official notice are translated and summarized here for informational and educational purposes, with full attribution to the original Japanese source.
